Phase 2
Completed N=100
A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFα Inhibitor Therapy
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00689728 ↗
Enrolled (actual)
100
Serious AEs
3.2%
Results posted
Dec 2018
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology (ACR)50 Response at Week 16 — 11.4; 14.3; 2.9 Percentage of Participants — p=0.178
Summary
The purpose of this study is to explore whether LY2127399 is effective in relieving signs and symptoms of rheumatoid arthritis (RA) in patients with a history of inadequate response or intolerance to at least 1 Tumor Necrosis Factor-Alpha (TNFα) inhibitor therapy. Examples of these TNFα inhibitor therapies that are currently on the market include Enbrel® (etanercept), Remicade® (infliximab), and Humira® (adalimumab).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology (ACR)50 Response at Week 16 |
11.4; 14.3; 2.9 | 0.178 |
| SECONDARY Number of Participants Experiencing An Adverse Event |
1; 2; 3; 0; 1; 0 | — |
| SECONDARY Change From Baseline in Medical Outcome Study 36-Item Short Form Health Survey (SF-36) at Week 16 |
5.064; 5.197; 1.229; 2.700; 3.597; 0.133 | 0.062 |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16 |
25.7; 28.6; 17.1 | 0.281 |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR)70 Response at Week 16 |
2.9; 3.6; 0 | 0.500 |
| SECONDARY Change From Baseline in Tender Joint Count at Week 16 |
-4.5; -6.3; -3.3 | 0.337 |
| SECONDARY Change From Baseline in Swollen Joint Count at Week 16 |
-2.6; -4.7; -2.3 | 0.403 |
| SECONDARY Change From Baseline in Participant's Assessment of Joint Pain at Week 16 |
-16.1; -17.8; -9.1 | 0.168 |
| SECONDARY Change From Baseline in Participant's Assessment of Disease Activity at Week 16 |
-20.2; -23.6; -11.2 | 0.157 |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16 |
-17.7; -17.3; -13.1 | 0.110 |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 |
-0.161; -0.259; -0.205 | 0.969 |
| SECONDARY Percent Change From Baseline in C-reactive Protein (CRP) at Week 16 |
58.88; 15.14; 71.64 | 0.554 |
| SECONDARY Change From Baseline in Disease Activity Score (DAS28) at Week 16 |
-0.911; -1.288; -0.613 | 0.100 |
| SECONDARY Number of Participants With Response (Response Rate) Based Upon European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) at Week 16 |
5; 5; 0; 8; 12; 15 | 0.022 sig |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 16 |
2.5; 7.9; 3.1 | 0.818 |
| SECONDARY Pharmacodynamics: Change From Baseline in Absolute CD20 + B Cell Count at Week 16 |
-30.94; -34.92; 0.79 | 0.010 sig |
| SECONDARY Pharmacodynamics: Change From Baseline in Total B Cells (CD20 + CD3-) as a Percentage of Total Lymphocytes |
-2.26; -2.20; -0.59 | 0.001 sig |
| SECONDARY Pharmacodynamics: Change From Baseline in Serum Immunoglobulins at Week 16 |
-0.83; -1.33; -0.62; -0.27; -0.24; -0.05 | 0.146 |
| SECONDARY Pharmacokinetics: Predicted Population Mean Parameter: C-trough Steady-state |
5.84; 18.9 | — |
| SECONDARY Pharmacokinetics: Predicted Population Mean Parameter: T-half Life (t1/2, Tau) |
19; 22 | — |
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent approval
- Women must not be at risk to become pregnant during study participation
- Diagnosis of Rheumatoid Arthritis
- Active Rheumatoid Arthritis
- Current, regular use of Methotrexate, at a stable dose
- Have been on at least 1 biologic tumor necrosis factor-alpha (TNFα) inhibitor therapy and either failed or were intolerant to treatment
- Other criteria to be reviewed by study doctor
Exclusion Criteria
- Use of excluded medications (reviewed by study doctor)
- Have medical findings which, in the opinion of the study doctor, put patient at an unacceptable risk for participation in the study
- Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation
- Evidence of tuberculosis
- Have systemic inflammatory condition other than rheumatoid arthritis (RA), such as juvenile RA, seronegative spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis.
- Other criteria to be reviewed by study doctor
Data sourced from ClinicalTrials.gov (NCT00689728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.